Official recall notice
FDA DrugClass IINotable
FDA Recall: Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL O
- Recall date
- 2026-07-29
- Category
- Drug
- FDA class
- Class II
Why it was recalled
Hazard
Lack of Assurance of Sterility
Product description
Lack of Assurance of Sterility
Affected products
Lot #: 4B1V, 4B1VA, Exp. Date 2027/01; 4J1V, Exp. Date 2027/09